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Clinical Performance of the Diassess Influenza A and B Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035396
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Diassess Inc.

Brief Summary:
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test

Condition or disease Intervention/treatment Phase
Influenza, Human Influenza Flu Device: Diassess Influenza A and B Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Clinical Performance of the Diassess Influenza A and B Test
Actual Study Start Date : December 29, 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Diassess Influenza A and B Test Device: Diassess Influenza A and B Test



Primary Outcome Measures :
  1. Diassess test measurement agreement with Polymerase Chain Reaction (PCR) [ Time Frame: One (1) patient visit which is a time frame of one (1) hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
  • Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough

Exclusion Criteria:

  • Subject received nasal vaccine (e.g. FluMist) within the past 10 days
  • Subject has been taking or took any antivirals for influenza in the past 30 days
  • Subject enrolled in any drug trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035396


Locations
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United States, New York
University Health Care Center
Syracuse, New York, United States, 13202
Sponsors and Collaborators
Diassess Inc.
Investigators
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Study Director: Carol Chen, PhD Diassess Inc.

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Responsible Party: Diassess Inc.
ClinicalTrials.gov Identifier: NCT03035396     History of Changes
Other Study ID Numbers: DIA 01A-CLI-002
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases